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Generated: February 17, 2018

DrugPatentWatch Database Preview

Zolpidem tartrate - Generic Drug Details

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What are the generic drug sources for zolpidem tartrate and what is the scope of zolpidem tartrate patent protection?

Zolpidem tartrate
is the generic ingredient in seven branded drugs marketed by Magna Pharms, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharma Global, Synthon Pharms, Biovail Labs Intl, Acme Labs, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Vivimed Global, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys Labs Inc, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in forty NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has two hundred and forty-nine patent family members in thirty-six countries.

There are thirty-two drug master file entries for zolpidem tartrate. Sixty-four suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for zolpidem tartrate
Pharmacology for zolpidem tartrate
Tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up5MGTABLET;ORAL
➤ Sign Up➤ Sign Up10MGTABLET;ORAL
➤ Sign Up➤ Sign Up10MGTABLET;ORAL

US Patents and Regulatory Information for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 204503-002 Nov 18, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078129-001 Apr 30, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078413-002 May 4, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Torrent Pharms ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077903-001 Aug 17, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 090153-002 Mar 25, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vivimed Global ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 076062-002 Apr 23, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077322-001 Apr 23, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 202657-001 Aug 8, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078616-002 Nov 21, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 076410-002 Apr 23, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992 ➤ Sign Up ➤ Sign Up
Magna Pharms ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for zolpidem tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,998,110 Buccal, polar and non-polar spray or capsule ➤ Sign Up
6,676,931 Buccal, polar and non-polar spray or capsule ➤ Sign Up
9,078,816 Buccal, polar and non-polar spray containing ondansetron ➤ Sign Up
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain ➤ Sign Up
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system ➤ Sign Up
8,097,431 Methods and compositions for detecting steroids ➤ Sign Up
8,454,996 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
7,910,132 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
7,632,517 Buccal, polar and non-polar spray containing zolpidem ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for zolpidem tartrate

Supplementary Protection Certificates for zolpidem tartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 Finland ➤ Sign Up
2015000006 Germany ➤ Sign Up PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
636 Luxembourg ➤ Sign Up PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0714 Netherlands ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2015 00004 Denmark ➤ Sign Up PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
00714 Netherlands ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
US Army
Healthtrust
Express Scripts
Chinese Patent Office
Colorcon
Fuji
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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